Effect of MTX Discontinuation on Shingrix Response in RA

Not Applicable
Recruiting
Conditions
Interventions
Registration Number
NCT06574594
Lead Sponsor
Konkuk University Medical Center
Brief Summary

The goal of this clinical trial is to learn if methotrexate discontinuation affect on immunogeneity of shingrix in RA patients. The main questions it aims to answer are:

Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ?
...

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
110
Inclusion Criteria
  • fulfill 2010 ACR/EULAR classification criteria for rheumatoid arthritis
  • age over 19 years
  • methotrexate user
  • agree for vaccination with shingrix
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Exclusion Criteria
  • have other form of inflammatory arthritis or autoimmune-mediated disease
  • malignancy, current infection, pregnancy
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
MTX discontinuationMethotrexatemethotrexate stop for 2 weeks after each shingrix vaccination
MTX continuationMethotrexate-
Primary Outcome Measures
NameTimeMethod
Cell-mediated immunity (CD4+ and CD8+ T cell against herpes zoster)baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination
Secondary Outcome Measures
NameTimeMethod
, Humoral immunity (anti-VZV antibody, anti-gE antibody)baseline (before 1st vaccination), 1 months later from 2nd vaccination, 3 months later from 2nd vaccination

Trial Locations

Locations (1)

Konkuk University Medical Center

🇰🇷

Seoul, Korea, Republic of

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